Devices vs Drugs

Difference between medical devices and pharmaceuticals

 

 

Medical Devices

 

Drugs

Industry Composition

 

Over 80% small and medium-sized companies

 

Very large multinationals dominate


Active Components

 

Generally based on mechanical, electrical and materials engineering

 

Based on pharmacology and chemistry; now encompassing biotechnology, genetiengineering etc

Pharmacologic properties and action of active ingredients are known, based on pre-clinical and clinical studies

Standardised batch sizes, manufacturing processes and starting materials

Products stable/generally stored at room temperature with a long shelf life


Product Development

 

Wide variety of products and applications – from thermometers to x-rays

Designed to perform specific functions and approved on the basis of safety and performance

Often developed by health professionals

 

Products are usually in the form of pills, solutions, aerosols, or ointments

Product development by discovery, trial, and approved on basis of safety and efficacy

Products developed in laboratories by chemists and pharmacologists


How Products work

 

Most act through physical interaction with the body or body part

 

Products are administered by mouth, skin, eyes, inhalation, or injection and are biologically active; effective when absorbed into the human body. Often act systemically on the entire body


Intellectual Property Concerns

 

Continuous innovation and iterative improvements based on new science, new technology, and new materials

 

Extensive research and development of a specific compound or molecule; takes several years for a new drug to enter the product pipeline


Product Life Cycle

 

 

Short product life cycle and investment recovery period (~18 months on market)

 

Little patent linkage possible. Data exclusivity is important 

Intensive patent protection, including data exclusivity and patent linkage, needed due to extensive product life cycle and long investment recovery period


Innovation

 

Majority of new products bring added functions and clinical value based on incremental improvements

 

Usually large step innovation


Support Provided

 

 

Large investment in manufacturing, distribution, and training/education; plus need to provide service and maintenance (for many high tech devices)

 

Low manufacturing and distribution cost, and, in most cases, no training, service or maintenance costs